Title: Forms & Templates Research Financial Compliance Monitoring Program Relates to Policy/Procedures: 2006-12 SOP#: 802-09 Version 7.0 Prepared by: Judie Fine Original date: 7/30/09 Approved by: Judi Kulko Date approved: 8/24/16 Purpose and Applicability: Documents and templates in this section are used in the Program Background and Significance: Please see SOP 800-09 Scope: These forms and templates facilitate interaction between the OCTR, the PIs and/or PI designee; standardize the auditing process as well as the office procedures related to documenting audits. Responsibilities: The OCTR Executive Administrator and appropriate staff are responsible for the design, development and appropriate use of these forms and templates. Procedural Steps: NOTE: The header in this SOP is applicable only to the leading two pages listing forms, and not to individual documents, which are routinely edited to reflect changes in usage and/or procedures. Changes to individual documents are noted on each document page. Form labeled A: Memorandum template with notification of pending audit, with enclosure used (2 pages) Form labeled B: Financial Compliance Audit Form (internal form - 2 pages) From labeled C: Basic Audit Tool template, modified for each audit as appropriate to the study design and the Budget Workbook Patient Calendar; problem sheet" to be attached to each patient's Audit Tool Form labeled D: Research Financial Compliance Audit Schedule Column headings for Excel spread sheet on OCTR Shared Drive Form labeled E: Letter template to PI with preliminary audit findings - with "Preliminary" watermark (3 pgs) Form labeled F: Letter template to PI with final audit findings (with "Final" Watermark Form labeled G: email template with final audit summary to Associate Dean Clinical for Research Planning and Administration, Associate Vice President Sponsored Programs and Services and Director of Sponsored Programs and Services Form labeled H: email template to PI with appreciation and acknowledgement of audit closure SOP 802-09 1 of 25
Title: Forms & Templates Research Financial Compliance Monitoring Program Relates to Policy/Procrdures: 2006-12 SOP#: 802-09 Version 7.0 Prepared by: Judie Fine Original date: 7/30/09 Approved by: Judi Kulko Date approved: 8/24/16 Form labeled I: Research Financial Compliance Audit Requirements emailed to Study Coordinator after Notification of Audit Form labeled J: Research Financial Compliance Audit Checklist specific to each audited study Form labeled K: Check list for contents of paper audit file & shared drive to be taped to inside cover of paper file Form labeled L: UMG Research Study Billing Reversals Form labeled M: JDH Research Study Billing Reversals Form labeled N: Research Study Missing Charges 8/11/11;2/28/14; 8/24/16 D. Clavette Reason for revision: 7.0 Name changes 5.0 To add new forms L. M and N 4.0 To change Forms labeled A, G & I. In order to insert current names. 8/24/16 SOP 802-09 2 of 25
Email accompanying the Notice of Audit Memorandum A Dear Dr. Your study IRB # xx-xxx-x Study Name has been identified for a routine research financial compliance audit. OCTR will contact xxx (study coordinator) to schedule a date for the review. The attached memo provides details. The audit should be conducted prior to (date). Please contact me at x8924 with any questions about the memo or audit. Thank you SOP 802-09 3 of 25
MEMORANDUM To: From: Date: Subject: Study to be audited: XXXX., Principal Investigator Judi Kulko, MSN Executive Administrator, Office of Clinical and Translational Research XX/XX/XX Research Financial Compliance Monitoring Program XXXXXXXX The (OCTR) of the UConn Health is committed to the improvement of the quality, efficiency, integrity and compliance in our research environment and activities. In pursuit of this commitment, the OCTR supports a Research Financial Compliance Monitoring Program to assess financial compliance with federal, state and institutional policies pursuant to billing activities and clinical research. The objective of the Financial Compliance component of the Quality Assurance (QA) Program is to ensure that subject billing adheres to the regulations set forth in the Medicare National Coverage Decision for Institutional Review Board (IRB) approved clinical protocols. IRB XXXX; XXXXXXXXXXXXX has been selected for the purpose of a financial compliance audit. The audit staff will phone your office within the next week to arrange for a mutually agreeable time to conduct the audit. The target date for the audit is XX/XX/XX. A pre-audit interview will be conducted with you and the study coordinator to discuss this research study and related financial compliance issues. This interview will involve approximately 10 minutes of your time. Your presence during the course of the audit is not necessary. Availability of a conference room or quiet area for the day for the audit staff to review patient records and other associated documents will be necessary. Documents pertaining to your clinical research will be held strictly confidential. Please contact, (insert name); at 8924 if you have any questions or concerns. Enclosure (1) SOP 802-09 4 of 25
Enclosure accompanying Audit Memorandum IRB Process FINANCIAL COMPLIANCE AUDIT ACTIVITIES MAY INCLUDE: Dates of approval and start of research Changes in protocol Budget and Billing process Review of contract Review of approved budget Review of protocol induced costs paid by the sponsor Review of routine care costs paid by third party payer/participant Review of all patient charges/billing Review of any charges/billing for adverse events Review of billing process within the department (adherence to UCHC SOPs) Review of charges billed to the study FRS account # Changes in budget Changes in contract Records regarding Subjects Documentation of research intervention Subject accrual Documentation Review of research records Review of clinic/medical records Reason for revision: Take off contact name in order to have current person to insert name. SOP 802-09 5 of 25
B Internal form FINANCIAL COMPLIANCE AUDIT FORM Principal Investigator: Study Name: IRB #: BANNER account #: Source Documentation Policies Documents Yes No Comments Sponsor identified Budget provided by sponsor Contract provided. Consent identifies services that are PIC and RC Compensation for patient injury is the same in contract and consent Consent, Protocol, Budget all concur regarding patient services and payment for patient services BEAN number in source documentation Case numbers are available IND # IDE # Appropriate approval from MAC for IDE studies Is this a qualifying study under CMS guidelines For IDE studies and carotid stent registries, appropriate notification has been submitted to MAC for payment preapproval compared to source documentation for services provided and required services per protocol Hospital charges were reviewed in IDX ADT Results Individual PIC patient charges were checked and SOP 802-09 6 of 25
UMG charges were reviewed in IDX BAR Representative sample of charts were reviewed Were errors found in billing (describe in attachment) Is this a departmental problem Is it a system problem All charges reversed; AUDIT CLOSED SIGNATURE: Judi Kulko, MSN, MS, RN Executive Administrator, OCTR Date SIGNATURE: Financial Compliance Auditor Reason for revision: SOP 802-09 7 of 25
Example of template for Basic "Audit Tool" (Tool is unique to each study) C Internal Form Medicare Qualifying Form reviewed: XX yes (not Medicare eligible) no NA IDA Qualifying Form reviewed: yes no XX NA Correct discounts reviewed and taken: yes no NA Patient Name: TO# Case # Date ICF signed: Date randomized: Note: No routine care indicated in Budget Workbook Additional space for notes on page 4 CPT description UMG/JDH 99204 99xxx Comprehensive/moderate OP visit-new screening visit UMG 94010 Spirometry JDH date PIC charged to study? PIC erroneously charged to insurance? Other billing errors Comments 99195 (from packet) Screening visit blood draw * JDH 94240 Screening functional JDH residual capacity/volume 94720 Screening carbon UMG monoxide diffusing capacity 94720 Screening co diffusing JDH capacity 99xxx Baseline OP visit UMG budget workbook = T & E only * protocol, packet and BW indicate 2 blood draws; ICF indicates 3 blood draws 93320 Baseline visit Doppler ECHO 93320 Baseline visit cardiac Doppler 93000 Baseline visit ECG (BW) UMG JDH UMG SOP 802-09 8 of 25
93040 (from packet) 93501 Baseline visit right heart catheterization UMG Reason for revision: SOP 802-09 9 of 25
Example of problem Sheet to be attached to each patient's Audit Tool PROBLEM SHEET: IRB# (insert Number), (insert protocol), (insert PI) Pt last name case #: Reason for revision: To take off name in order to insert current name. SOP 802-09 10 of 25
Research Financial Compliance Audit Schedule D Column headings on Excel spread sheet on OCTR Shared Drive audit month FY 2011 send email memo re audit OCTR set up audit date by audit to be completed by - date date of audit & completion of Fin Comp Audit Form draft letter due to JK1 preliminary letter sent to PI date PI response due final letter sent to PI date PI response due date letter sent to Res Adm & closed PI & coordinator IRB# study name fragment & sponsor Reason for revision: SOP 802-09 11 of 25
E Date Letter template to PI with preliminary audit findings with "Preliminary" watermark (3 pgs) Dr. XXX XXXXX Department MC #### University of Connecticut Health Center Regarding: IRB # YY-###-1 Name of Study I am writing to provide you with the preliminary results of the MM/DD/YY research financial compliance audit on the above mentioned study. The purpose of such audits is to provide a systematic internal process that will increase compliance with Federal, State and institutional regulations and policies. The research financial compliance monitor conducted the audit with your study coordinator, YYY YYYYYY. Study Summary: The purpose of this study is to demonstrate that Patient Injury Language: The final contract and patient consent were reviewed to check for consistency in patient injury language in both documents and XX issues were identified. Notification of Medicare Administrative Contractor (MAC): Per Center for Medicare & Medicaid (CMS) policy, appropriate verification was obtained by study coordinator from our MAC to support Medicare patient participation and Medicare payment for patient participation in the XXX trial Budget Workbook: Per UConn Health policy, a budget workbook was completed for this study prior to IRB approval. This workbook was used as a template to review Protocol Induced Costs (PIC) and Routine Clinical Services (RC). Patient Charges: Actual dates of patient PIC and RC services were identified in the patient research record. If discrepancies in dates of service were identified, the patient Lifetime Clinical Record (LCR) was reviewed. IDX, the UConn Health billing program, was then used to verify if PICs and RCs were billed correctly to research and insurance respectively. Findings: A total of ## patients signed consent to participate in this clinical trial. Patient xxxxx was a screen failure; patient yyyyy did not participate in the study and patient Routine Clinical Services All routine clinical services identified in the budget workbook were billed correctly to the patients insurance for JDH charges. Patient.zzzzz had all UMG charges for xxxxx procedure done on MM/DD/YY erroneously charged to the research study. SOP 802-09 12 of 25
Patient qqqqq had all UMG charges for xxxxx procedure done on MM/DD/YY erroneously charged to the research study. Protocol Induced Costs Protocol induced costs identified in the budget workbook and designated as being paid by the sponsor included The findings are as follows: The xxxxx examination required by the study was done per protocol by xxx xxxx, for each patient. No specific charges were found for this service. This was designated as a protocol induced cost for which the sponsor paid. Therefore, a visit should be charged to the study for each of these examinations, or her time should be charged to the research account as T&E. XXX, (which include JDH charges to do the XXX and UMG charges to read the XXX), for patient zzzzz was charged correctly to the research through use of the case number. Errors were found in the remaining five patients and are delineated below: 1. Patient ccccc: 2. Patient rrrrr: 3. Patient ooooo: 4. Patient eeeee: UMG has been notified of the error for patient ccccc and patient kkkkk and the routine clinical services related to the xxx procedure have been charged correctly to each patient s insurance to avoid non-payment due to time limitations. The remainder of the UMG charges billed erroneously to insurance and the T&E for the xxxxx exams will be charged to the research as soon as we receive confirmation from you that you have reviewed these findings and have no further comments. We would like to thank your staff, specifically, YYY YYYYYY, for her participation in this monitoring process. Please respond to these preliminary findings within 15 days (by MM/DD/YY) with any comments or questions. If there are no changes to this report, the charges in question will be corrected and this report will be distributed to Research Administration. Regards, Judi Kulko, MSN, MS Executive Administrator Reason for revision: SOP 802-09 13 of 25
Date F Letter template to PI with final audit findings (with "Final" watermark Dr. xxxx Department MC #### University of Connecticut Health Center Regarding: IRB # YY-#### name of study This is the final report of the mm/dd/yyyy research financial compliance audit on the above mentioned study. The purpose of such audits is to provide a systematic internal process that will increase compliance with Federal, State and institutional regulations and policies. The research financial compliance monitor conducted the audit with your study coordinator, xxx yyyyy. Study Summary: The purpose of this study is to demonstrate Patient Injury Language: The final contract and patient consent were reviewed to check for consistency in patient injury language in both documents and no issues were identified. Notification of Medicare Administrative Contractor (MAC): Per Center for Medicare & Medicaid (CMS) policy, appropriate verification was obtained by study coordinator from our MAC to support Medicare patient participation and Medicare payment for patient participation in the xxxxx which is an Investigational Device Exemption (IDE) study. Budget Workbook: Per UConn Health policy, a budget workbook was completed for this study prior to IRB approval. This workbook was used as a template to review Protocol Induced Costs (PIC) and Routine Clinical Services (RC). Patient Charges: Actual dates of patient PIC and RC services were identified in the patient research record. If discrepancies in dates of service were identified, the patient Lifetime Clinical Record (LCR) was reviewed. IDX, the UCHC billing program, was then used to verify if PICs and RCs were billed correctly to research and insurance respectively. Findings: SOP 802-09 14 of 25
A total of xx patients signed consent to participate in this clinical trial. Patient T00 ##### was a screen failure; patient T0 #### did not participate in the study and patient T00 #### participated in the trial twice and was counted as two separate subjects. Routine Clinical Services All routine clinical services identified in the budget workbook were billed correctly to the patients insurance for JDH charges. Patient.T00 #### had all UMG charges for xxxx procedure done on mm/dd/yy erroneously charged to the research study. Patient T0 #### had all UMG charges for xxxx procedure done on mm/dd/yy erroneously charged to the research study. Protocol Induced Costs Protocol induced costs identified in the budget workbook and designated as being paid by the sponsor included one pre-discharge ECG and three neurologic examinations per eligible patient. The findings are as follows: The xxx examination required by the study was done per protocol by xxx yyy, for each patient. No specific charges were found for this service. This was designated as a protocol induced cost for which the sponsor paid. Therefore, a visit should be charged to the study for each of these examinations, or her time should be charged to the research account as T&E. xxxs, (which include JDH charges to do the xxx and UMG charges to read the xxx), for patient T00 #### and patient T00 #### were charged correctly to the research through use of the case number. Errors were found in the remaining seven patients and are delineated below: 5. Patient T00 #### 6. Patient T00 #### 7. Patient T00 ### 8. Patient T00 ### 9. Patient T00 #### 10. Patient T00 ##### 11. Patient T0 #### UMG has been notified of the error for patient T00 #### and patient T0 #### and the routine clinical services related to the xxx procedure have been charged correctly to each patient s insurance to avoid non-payment due to time limitations. Please respond to the findings of this audit by mm/dd/yy and outline an action plan to correct the following deficiencies: SOP 802-09 15 of 25
Charging T&E for the xxx examinations done by your Study Coordinator to the study Reversing charges and billing research for seven UMG charges for xxxs that were erroneously billed to insurance. If you have any questions please do not hesitate to contact me at 1395. Regards, Judi Kulko, MSN, MS Executive Administrator CC: P. Albertsen M. Glasgow P. Hudobenco Reason for revision: SOP 802-09 16 of 25
G Email template with final audit summary Email to: Peter Albertsen, M.D., Associate Dean Clinical Research, Planning, and Coordination Mike Glasgow, Associate Vice President Sponsored Programs and Services, Paul Hudobenco, Director of Sponsored Programs and Services From: (Insert Name), Office of Clinical and Translational Research Date: Regarding: IRB YY-####-# name of study and PI name Attached, please find the final report for the research financial compliance audit of the study named above. (Insert Name) Administrative and Clinical Research Coordinator Office of Clinical and Translational Research UConn Health (860) 679-(extension) (Name)@uchc.edu SOP 802-09 17 of 25
H Email template following audit Date Dr. xxx yyyy Department MC 0000; UConn Health Regarding: IRB YY-####- Dear Dr. yyyy, We appreciate your and your staff s cooperation in conducting this research financial compliance audit. We have received your response to the audit findings and will await a request from bbbb ddddd to meet with her, Department staff, and mmm tttttt to resolve any outstanding issues. Once those issues have been resolved, we will consider this audit closed. Regards, Judi Kulko, MSN, MS Executive Administrator Reason for revision: SOP 802-09 18 of 25
Research Financial Compliance Audit Requirements form Sent via email to Study Coordinator I Research Financial Compliance Audit Requirements Date of audit: Principal Investigator: IRB #: Name of study: Recruiting status (e.g., recruiting, closed to accrual, study closed): At least ten days prior to the audit, please email the following information to OCTR: List of enrolled patients, including screen failures, with the following: 1. Patient name 2. TO # 3. Case # 4. Study ID # 5. Date randomized, if applicable Please reserve a room with space for three people. Room # is reserved. The day of the audit, the following must be available for review: Research charts Clinic/medical records for each patient, including screen failures Please note: Inpatient studies must have inpatient records available If you have any questions, please contact (insert name) at x 8924 or (name)@uchc.edu Reason for revision: To insert name of current contact. SOP 802-09 19 of 25
Research Financial Compliance Audit Checklist/specific for each study Internal form J Research Financial Compliance Audit Checklist (addendum to OCTR SOP 802-09) IRB#: Study name (fragment): PI: Date of Audit: On a quarterly basis: randomly select trials to be audited, by month using Audit Calendar Tickler (xls) on Shared Drive, enter dates for emails, calls, draft results letter, etc. First week of month preceding audit month (e.g., first week in November for December audit): email audit memo to PI, covering study coordinator (template in SOP 802-09A) with accompanying "audit activities" enclosure Two weeks prior to each monthly audit: obtain IRB-approved ICF from study coordinator print Patient Services Calendar from final budget workbook x 3 (for each auditor) review Budget Workbook for completeness review Medicare qualifying form review IDE qualifying form (if applicable) request list of enrolled patients, including screen failures, from study coordinator; request patient name, TO#, case #, study ID#, date ICF signed, date randomized and study recruiting status using final version of study protocol, IRB-approved ICF, preliminary Budget Workbook packet, and Budget Workbook patient calendar, develop study-specific Audit Tool form, addressing on the form, any questions and/or inconsistencies uncovered in the review, as appropriate decide if all patients will be audited, or a randomly-selected percentage of patients prepare list of selected patients for study coordinator; include patient name, TO#, and case #; email to study coordinator or RN; include in that email: NB: research charts as well as patient medical records must be available the day of the audit to provide source documentation after patient selection and Audit Tool completion, prepare Audit Tool form for each case selected Day of audit: take all documents used in above review and preparation following patient chart reviews, and prior to leaving audit area, review and complete Financial Compliance Audit Form to make sure all items (documents, policies, etc.) have SOP 802-09 20 of 25
been addressed if major billing financial violations or substantive systematic deficiencies, see page 4 of SOP 801-09 Within two weeks following audit: if no major violations or deficiencies, undated draft of preliminary results of audit to be sent to Judi Kulko for review and approval; letter should note PI has 15 days from date letter is sent to review for accuracy and respond if there are comments and/or questions. after approval of draft preliminary results letter, date letter, add PI response date, send to PI and post date to Shared Drive If no problems with PI review are encountered, after PI's response time has elapsed: complete Financial Compliance Summary Form follow procedures on page 4 of SOP 801-09, under "final report of audit findings" Reason for revision: SOP 802-09 21 of 25
Check list for contents of paper audit file & shared drive to be taped to inside cover of paper file K IRB # xx-xxx-x Study Name: PI: Completed Research Financial Compliance Audit Checklist copy of letter closing audit copy of Final Results letter to PI, including email original, completed & signed Financial Compliance Audit Form copy of PI response to preliminary results letter preliminary results letter to PI, including copy of email Study Specific Audit Tool, with Problem Sheet and IDX print-outs attached, for each audited patient (n= ) copy of Budget Workbook patient calendar copy of enrolled patient list currently approved ICF PI notification of audit: email + attachment Appropriate documents in this file have been scanned and posted to the shared drive Reason for revision: SOP 802-09 22 of 25
L Internal Form UMG Research Study Billing Reversals Sponsor: Protocol: PI: IRB Number: Patient Name: T0 Number: Case Number: Invoice # Date Billed Procedure Correction Charge Code CPT Code Completed Completed by: Signature: Date: Reason for revision: SOP 802-09 23 of 25
M Internal form JDH Research Study Billing Reversals Sponsor: Protocol: PI: IRB Number: Patient Name: T0 Number: Case Number: Visit # Date Billed Procedure Correction Charge Code CPT Code Completed Completed by: Signature: Date: Reason for revision: SOP 802-09 24 of 25
N Internal form Research Study Missing Charges Sponsor: Protocol: PI: IRB Number: Patient Name: T0 Number: Case Number: Date Performed Procedure JDH or UMG CPT Code Bill to: Completed by: Signature: Date: Reason for revision: SOP 802-09 25 of 25